Numerous procedures have been developed that involve the percutaneous insertion of a medical device into a body vessel of a patient's body. Such a device may be introduced into the vessel by a variety of known techniques. For example, a wire guide may be introduced into a vessel using the Seldinger technique. This technique involves creating a minimally invasive opening in a vessel with a needle and inserting a wire guide into the vessel through a bore of the needle. The needle is withdrawn, leaving the wire guide in place. An introducer device is then inserted over the wire guide and into the vessel. The introducer device may be used in a conventional manner to insert into the body vessel a variety of medical devices such as catheters, guiding catheters, balloons, stents, stent grafts, and the like.
For example, an introducer device may be used to deliver and deploy an endoluminal prosthesis, such as a stent or stent graft, to treat a damaged or diseased body lumen such as a stenosis in a blood vessel. The introducer device may include a prosthesis that is radially compressed onto a delivery catheter and is covered by an outer sheath. To deploy the prosthesis, the operator withdraws the outer sheath distally over the delivery catheter, thereby exposing the prosthesis for outward expansion thereof.
One of the challenges associated with endoluminal procedures is controlling the flow of bodily fluids within the introducer device during the procedure. One or more mechanisms, such as valves may be provided when it is necessary or desired to control the flow of bodily fluids within the introducer device. For example, the introducer device may include a hemostatic valve to limit or prevent blood loss through the introducer device during a procedure.
Often, a single introducer device may be used to insert and/or deploy multiple medical devices during a procedure. For example, a single introducer device with a hemostatic valve may be used for introducing a delivery catheter for deployment of an endoluminal prosthesis within a vessel. Once the prosthesis is placed within the vessel, the introducer device with the hemostatic valve may also be used to deliver an interventional device or catheter, such as a balloon catheter, to the vessel to facilitate expansion of the deployed prosthesis. In this example, the hemostatic valve is able to provide a hemostatic seal under several conditions: (1) to seal against the delivery catheter carrying the endoluminal prosthesis when the delivery catheter is inserted into the introducer and through the valve; (2) to seal against the interventional catheter when the interventional catheter is inserted in the introducer and through the valve, and (3) to re-seal when the delivery catheter and/or the interventional catheter are removed from the introducer and valve.